Bipolar Disorder, High Triglycerides, Hypercholesterolemia, Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
Detailed description
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second generation) antipsychotic medication. Eligible subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. Atypical antipsychotics include: clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris), iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl at baseline.
Interventions
DRUGLovaza
4 grams per day
Sponsors
GlaxoSmithKline
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female or male patients, 18-75 years of age. 2. Serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl 3. Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months
Exclusion criteria
1. Current use of triglyceride or cholesterol-lowering medication other than a statin 2. Current use of omega-3 fatty acid supplement 3. Intake of fish more than twice per week 4. Currently pregnant, or breastfeeding 5. Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies) 6. Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc). 7. Consumption of alcohol greater than two drinks per day or active substance abuse 8. Any medical condition that would make participation in the study unsafe, as determined by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Triglycerides From Baseline to 16 Weeks | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol From Baseline to 16 Weeks | 16 weeks | — |
| Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) | 16 weeks | At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label Lovaza (Omega-3 Fatty Acids) 4g per day (4g once a day or 2g two times a day) for 16 weeks
Lovaza: 4 grams per day | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet eligibility criteria | 41 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Change in Triglycerides From Baseline to 16 Weeks
Time frame: 16 weeks
Population: Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Lovaza (Omega-3 Fatty Acids) | Change in Triglycerides From Baseline to 16 Weeks | -54.13 mg/dL | Standard Deviation 83.44 |
Secondary
Change in Total Cholesterol From Baseline to 16 Weeks
Time frame: 16 weeks
Population: Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Lovaza (Omega-3 Fatty Acids) | Change in Total Cholesterol From Baseline to 16 Weeks | -1.75 mg/dL | Standard Deviation 29.4 |
Secondary
Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)
At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).
Time frame: 16 weeks
Population: All participants who took at least one dose of the study medication were included in the analyzable population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open-label Lovaza (Omega-3 Fatty Acids) | Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) | non-tolerable | 1 Participants |
| Open-label Lovaza (Omega-3 Fatty Acids) | Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) | tolerable | 22 Participants |